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EC approves Bavarian Nordic’s chikungunya vaccine marketing
The European Commission (EC) has authorised the marketing of Bavarian Nordic's Vimkunya - the first chikungunya vaccine ...
Regeneron Gets Positive CHMP Opinion for Multiple Myeloma Drug
The CHMP recommends conditional marketing authorization of REGN's linvoseltamab to treat adults with relapsed and refractory multiple myeloma.
LEQEMBI Market Sales Reflect Growing Confidence In Disease-Modifying Alzheimer’S Treatments| Delveinsight
LEQEMBI (lecanemab) has significant market potential due to the high global prevalence of the condition and the demand for disease-modifying treatmen ...
Novartis Gets CHMP Opinion for Label Expansion of Fabhalta
The CHMP recommends granting a marketing authorization to NVS' Fabhalta for the treatment of adults with C3 glomerulopathy, an ultra-rare, progressive kidney disease with no currently approved ...
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ABBV Enters Obesity Bandwagon, Inks $2.2B Licensing Deal for Amylin Drug
AbbVie ABBV announced that it has entered into a licensing agreement with Denmark-based biotech Gubra for the latter’s ...
BioSpace10h
Biogen, Eisai Continue Leqembi’s European Rally as CHMP Reaffirms Positive Opinion
Leqembi’s application now moves forward to the European Commission, which will issue a formal verdict for the injection that ...
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Rare diseases: Novartis’ Fabhalta recommended by CHMP for C3 glomerulopathy
Approximately one to two people per million worldwide are diagnosed with the ultra-rare kidney disease every year ...
PMLiVE11h
Rare diseases: CHMP recommends Krystal’s Vyjuvek for dystrophic epidermolysis bullosa
The European Medicines Agency’s (EMA) human medicines committee has recommended Krystal Biotech’s Vyjuvek (beremagene ...
AstraZeneca says Imfinzi-based perioperative regimen recommended for EU approval
Imfinzi in combination with chemotherapy has been recommended for approval in the European Union for the treatment of ...
Eisai, Biogen announce TGA of Australia declined approval of lecanemab
Eisai (ESAIY) and Biogen (BIIB) announced that the Therapeutic Goods Administration, TGA, of Australia has confirmed the initial decision to ...
The Committee For Medicinal Products For Human Use (CHMP) Reaffirms Positive Opinion For Lecanemab In Early Alzheimer's Disease
Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble ...
Pharmabiz14h
EMA committee recommends approval of AbbVie’s upadacitinib to treat adults with giant cell arteritis
EMA committee recommends approval of AbbVie’s upadacitinib to treat adults with giant cell arteritis: North Chicago, Illinois Monday, March 3, 2025, 15:00 Hrs [IST] AbbVie annou ...